KARL STORZ ARTHROPUMP POWER IRRIGATION/SUCTION PUMP

K093471 · KARL STORZ Endoscopy-America, Inc. · HRX · Oct 18, 2010 · Orthopedic

Device Facts

• Record ID: K093471
• Device Name: KARL STORZ ARTHROPUMP POWER IRRIGATION/SUCTION PUMP
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Oct 18, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Karl Storz ARTHROPUMP POWER Irrigation/Suction Pump is intended for use by qualified surgeons to provide irrigation/aspiration to the surgical site during arthroscopic surgical procedures in the joints of the shoulder, knees, ankle, elbow, wrist, and hip.

Device Story

ARTHROPUMP POWER is a combined irrigation/suction pump for joint capsule dilation and irrigation. System includes pump unit, footswitch, and tubing; supports integrated shaver use. Microprocessor-controlled dual peristaltic pumps manage fluid and joint pressure based on user settings; flow and pressure can be adjusted individually. Used by surgeons in arthroscopic procedures to maintain pressure, perform lavage, and achieve hemostasis. Output allows surgeons to maintain clear visualization and stable joint distension during surgery, facilitating arthroscopic intervention.

Clinical Evidence

Bench testing only. Device tested for function, performance, and safety; all specifications met.

Technological Characteristics

Microprocessor-controlled dual peristaltic pump technology. Maintains user-set pressure and flow. Supports lavage and hemostasis. System includes pump unit, footswitch, and tubing.

Indications for Use

Indicated for use by qualified surgeons to provide irrigation and aspiration to the surgical site during arthroscopic procedures of the shoulder, knee, ankle, elbow, wrist, and hip.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Predicate Devices

• Future Medical Systems, Inc.: FMS Duo (K954465)
• Karl Storz: Arthropump Plus (K971649)

Submission Summary (Full Text)

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KARL STORZ Endoscopy-America, Inc. 2151 E. Grand Avenue El Segundo, California 90245

Toll Free 800 421 0837 Fax [phone]

OCT 18 2010
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### 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document are accurate and complete to the best of KSEA's knowledge.

Submitter:

Karl Storz Endoscopy-America, Inc. 2151 E. Grand Avenue El Segundo, CA 90245-5017 Phone: [phone] [phone] Fax:

Contact Person:

Regulatory Affairs Specialist Email: [e-mail]

Crystal Dizol

Date Prepared: September 16, 2010

Karl Storz ARTHROPUMP POWER Irrigation/Suction Pump Device Trade Name:

Common Name: . Arthroscopic pump

Classification Name: Arthroscope and accessories

Regulation Number: 21 CFR 884.1730

HRX Product Code:

#### Predicate Device(s):

Future Medical Systems, Inc .: FMS Duo (K954465) Karl Storz: Arthropump Plus (K971649)

#### Device Description:

The Karl Storz ARTHROPUMP POWER is a combined irrigation and suction pump for dilation and irrigation of joint capsules with a fluid. Both roller pumps are software controlled and automatically manage fluid and joint pressure based on settings chosen by the user. If desired, both flow and manage hald and joint proodividually adjusted. The device is used as part of a system that includes the unit, a footswitch and tubing, and can support integrated use of a shaver.

#### Intended Use:

The Karl Storz ARTHROPUMP POWER Irrigation/Suction Pump is intended for use by qualified The Ran Glorz An 11 in For only 1 Sweet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . the joints of the shoulder, knees, ankle, elbow, wrist, and hip.

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#### Technological Characteristics:

The KARL STORZ ARTHROPUMP POWER Irrigation Pump utilizes microprocessor controlled dual peristaltic pump technology to maintain user-set pressure and flow, and to also perform lavage and hemostasis as necessary.

#### Non-Clinical Performance Data:

The KARL STORZ ARTHROPUMP POWER has been tested for function, performance and safety Test results show that all specifications have been met.

#### Determination of Substantial Equivalence:

The Karl Storz ARTHROPUMP POWER Irrigation/Suction Pump is substantially equivalent to the predicate devices since the basic features, design, and intended use are similar. The minor differences between the Karl Storz ARTHROPUMP POWER Irrigation/Suction Pump and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the function or intended use of the devices. Where differences in performance or technology exist, it has been demonstrated that they do not adversely impact safety or effectiveness.

#### Conclusions:

The Karl Storz ARTHROPUMP POWER is substantially equivalent to the identified predicate devices and does not raise any new issues of safety and efficacy.

Att: Substantial Equivalence Table for Karl Storz ARTHROPUMP POWEF

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Karl Storz Endoscopy-America, Inc. % Ms. Crystal Dizol Regulatory Affairs Specialist 2151 East Grand Avenue El Segundo, California 90245-5017

## OCT 1 8 2010

Re: K093471

Trade/Device Name: Karl Storz ARTHROPUMP POWER Irrigation/Suction Pump Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: September 16, 2010 Received: September 20, 2010

#### Dear Ms. Dizol:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

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Page 2 - Ms. Crystal Dizol

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sincerely yours,

for Peter D
Mark N. Melkerson
DEP Dir

Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE

OCT 1 8 2010

510(k) Number (if known): k093471

Karl Storz ARTHROPUMP POWER Irrigation/Suction Pump Device Name:

Indications for Use: The Karl Storz ARTHROPUMP POWER Irrigation/Suction Pump is intended for use by qualified surgeons to provide irrigation/aspiration to the surgical site during arthroscopic surgical procedures in the joints of the shoulder, knees, ankle, elbow, wrist, and hip.

× Prescription Use: (21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use: _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nittededen for nxa

sion Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K093471